(189 days)
The Probe Covers for Thermometers are intended for use as barriers between thermometers and oral cavities or users' rectum. The subject devices are used as accessories for digital thermometers and intended for single use only.
The Probe Covers for Thermometers, which made of PE and EVA, are used for thermometers as barriers during oral or rectal temperature measurements. The Probe Covers are suitable for varied thermometers and non-sterilized packaging. A sandwich structure which is formed by the top and back paper and middle films.
The provided text is a 510(k) Premarket Notification for "Probe Covers for Thermometers" and outlines the device's characteristics and its substantial equivalence to a predicate device. It defines the device, its intended use, and its comparison to an existing device (Yu Long Sheng Disposable Thermometer Sheath, K102508).
However, the document does not describe a study that involves an AI/ML device, expert ground truth establishment, sample sizes for training/test sets, or detailed performance metrics like sensitivity, specificity, or AUC as one would expect for an AI diagnostic device. Instead, it describes compliance with engineering and biocompatibility standards for a physical medical accessory.
Therefore, I cannot extract the information required to populate the table and answer the subsequent questions about an AI/ML study. The provided text is solely about the regulatory clearance of a non-AI/ML medical device accessory.
Here's why I cannot fulfill your request based on the provided text:
- No AI/ML Device: The device is "Probe Covers for Thermometers," a physical accessory. It does not involve any artificial intelligence or machine learning component.
- No Diagnostic Performance Study: The "performance" section refers to compliance with ASTM E1104-98 (Standard Specification for Clinical Probe Covers and Sheaths) and ISO 10993 (Biocompatibility). These are standards for physical properties (leakage, toxicity, compatibility) and material safety, not for diagnostic accuracy or algorithmic performance.
- No "Ground Truth" as related to AI: Ground truth in an AI/ML context typically refers to validated medical conditions (e.g., presence or absence of a disease) established by experts, pathology, or outcomes for a machine to learn from or be tested against. For a thermometer probe cover, "ground truth" relates to physical specifications and material safety.
- No Human Reader Study (MRMC): There is no mention of human readers or comparative effectiveness studies with or without AI assistance, as the device is not a diagnostic tool that assists human interpretation.
Therefore, I must state that the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets them.
If you have a document describing an AI/ML medical device and its corresponding studies, please provide that, and I would be happy to help.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.